Robert Califf’s FDA with Maddie Bannon - podcast episode cover

Robert Califf’s FDA with Maddie Bannon

Apr 06, 202356 min
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Episode description

In this episode, Whitney is joined by Maddie Bannon to discuss FDA Commissioner Robert Califf and his role in removing regulatory obstacles for the "healthcare" related wearable, implantable devices and other emerging technologies seen as crucial to the advance of the 4th Industrial Revolution.

Show notes

Follow Maddie: TLAVagabond SubstackManufacturing Reality@llspacejellyll

Originally published 04/03/23.

Transcript

WW

Hey and welcome to unlimited Hangout. I'm your host Whitney Webb. For a little over a year, the American Food and Drug Administration or FDA has been led by a man named Robert Califf. Very few people seem to know much about Califf or his background, and there is very little critical reporting on this man despite the power he currently wields over

significant aspects of American public health policy. During his confirmation hearings last year, there were a few stories here and there noting Califf's investments in the pharmaceutical and biotechnology industries as well as his long standing ties to Big Pharma and how this might present a conflict of interest. Yet there is a deeper problem with Califf, that goes far beyond these conflicts of interest that more often than not, are the norm within the US federal government

and on Capitol Hill. This is Califf second stint as FDA commissioner, having previously held the post toward the end of Barack Obama's second term. After he left that position. When Donald Trump took office in early 2017. Califf joined Google becoming the Silicon Valley giants top strategist for its forays into healthcare specifically for Google's health

focus subsidiary, verily Life Sciences. Ever since then, Califf has been at the vanguard of the effort to kickstart the so called Fourth Industrial Revolution, or for IR in healthcare, and this has extended into the decisions he

has overseen over the past year as head of the FDA. Perhaps unsurprisingly, Califf himself is a major evangelist for the for IR in healthcare and is on record stating that he shared the four IR vision of World Economic Forum Chairman Klaus Schwab well before his notoriety during the COVID era, her Schwab and his allies, the four IR, particularly as it relates to health care, is about the merging our physical, digital and biological cells, essentially transhumanism by a

different name. troublingly as FDA commissioner Califf is already creating regulatory loopholes for devices that will bring this dark vision to fruition, including brain machine interfaces, neuromodulation devices and surveillance wearables, among others. He is also doing the same with other four IR health focus technologies, including gene therapies and much more. For those Americans who are concerned about the push to inject the four IR into the

American health care system and into our bodies. Robert Califf is the man to watch. Joining me today to discuss Kayla from the deeper problems here is Maddie Bannon investigator Researcher and Contributor to the last American Vagabond substack. Last year, Maddie published a deep dive on K lift called Brave New real world data on the tlap substack which focused on Califf's time before he became FDA commissioner and his love affair with the World Economic Forum in the idea of the Fourth

Industrial Revolution. I highly recommend anyone interested in Califf from the broader issues at play here. Give Matt his piece of read. With that being said, welcome to unlimited hangout. Maddy, it's great to have you here.

MB

Oh, thanks for having me.

WW

Absolutely. So, as I mentioned just a minute ago, it's been acknowledged, right that Robert Califf has a concerning conflict of interest with Big Pharma, which is, as you noted in your article, you know, Bernie Sanders, among others have challenged him on this. So I guess before we get into some of the other key aspects about Califf here, particularly about the four IR and things like that, let's talk a little bit about his his connections to Big Pharma. Sure.

MB

Well, first of all, is Gousto trial, which was a mega trial, over 40,000 participants in the study of cardio, mild infarction, which is the heart attack was funded a lot by bear, Sanofi GlaxoSmithKline on all the big names. So he's been receiving funding from the big pharmaceutical industries for the majority of his career, most of his papers that he's issued, and he he, a lot of people, when they're interviewing him, are sure to make note of that he's one of the most cited medical

writers in the field. They're sure to make note that for as many papers, it's like, over 1200 that is accomplished. They're all punctuated by very long conflict of interest statements that lists, you know, dozens and dozens of pharmaceutical companies. So he has a very cozy relationship with all of them.

WW

Right. But I guess one of the things I want to talk about today is that and what I've talked about in some of my work over the past couple of years, is that big pharma and big tech have essentially been coming together creating a lot of joint ventures. And so what has been sort of emerging over the same timeframe is you know, where As there was previously, this well known revolving door between, you know, the FDA and Big Pharma and other, you know, health care focused agencies like HHS and

Big Pharma. Now, there's a revolving door between those health agencies and big tech firms like Google. So Califf is one of these guys, of course. But there's actually quite a few. So if you go to the Google Health About Us page, now that Califf is, you know, more or less, not officially a big part of it. But as you note in your PC still is very much connected

to Google Health and its initiatives there. But their new chief health officers, a lady named Karen DiSalvo, she was formerly the National Coordinator for Health Information Technology, and Assistant Secretary for Health in the Obama administration. And prior to that worked in HHS. And then we have Dr. Michael Howell, who is at Google Health Chief Clinical Officer and Deputy Chief Health Officer. He's an

adviser to the Centers for Disease Control. And then one of the newest hires at Google Health as a man named Bakul Patel, who's Senior Director of global digital health strategy, and I guess the relationship with regulatory agencies. And he was, he'd been at the FDA for decades before joining Google most recently as the FDA is Chief Digital Health Officer of global strategy and innovation. So there's a lot of these guys, but of course, probably the most important one to point out would

be Califf. So as I mentioned in my intro, Califf was, of course at the FDA during the Obama administration, and then he joined Google. So I guess maybe you could tell us a little bit about his time at Google and why that's significant.

MB

Sure. So he'll have served as the Commissioner for the FDA between the years of 2016 and 2017. And that was his first stent under the Obama administration. During that time, the 21st Century Cures Act was passed, which is a very important piece of legislation that kind of allows for all the, you know, very new breakthrough devices and E ways and the waiver of informed consent for minimal risk trials. So that was passed during his time there. But he did leave in 2017. That's

when he went back to do for a couple of years. And he founded Duke Forge. But in 2019, he joined verily Life Sciences as their their head of like health strategy and policy. During that time, he headed project baseline, which that is basically,

you know, huge mega trial. Along the lines of the things that he's already very interested in NS projects at Duke, including the Duke Clinical Research, initiative, and clinical CTTI, which is clinical trials Transformation Initiative, where they're aiming to use digital infrastructure, passively collected patient data,

including electronic health records. So project baseline at fairly, was kind of a replication of that at a major private company, who he said has the funding to do it, right, which is what he is on, on record noting is very important. He wants as much money as he can get to get these studies to be what he actually wants. So Verily, you know, they recruit people to join these studies, they had a wearable, a proprietary watch, that is by prescription only that sense,

you know, biometric data back to Google for to be studied. They studied a number of things, including, you know, oral health and how that relates to overall health. And you know, the impacts of daylight savings time on your restiveness and overall well being based, they studied a number of very trite things, you know, that I don't think really, not a lot of these study results, while they are posted on clinical trials.gov. The results are not posted there. So I'm not sure what the results

were. But they also study things like depression. So yeah, that's basically their their whole thing is to continuously monitor and collect data, because on the people that are involved in their studies, because their goal is to map human health. They said, we already have mapped the earth and now it is time to map human health and that's kind of what they're out. her.

WW

Yikes. Yeah. So they've mapped human health and they contract with like intelligence agencies in the military. So they can, you know, like drone bomb or find whoever they want. Right. And so now we got them got a map the human body to Well, that's fun. Okay, so one thing I really found interesting as a major theme in your article is this about clinical trials specifically about bailiff. So as you noted, you know, he made a name for himself with this, um, I guess Gousto trial in the

in the mid 90s. But since then, he's essentially been trying to revolutionize clinical trials and how they're performed. And so a lot of the stuff you've touched on, including project baseline, I'd like to get in into a little more detail of those specific initiatives like that. And other ones you

mentioned a little bit later in this episode. But for now, I just wanted to bring up that you noted in your piece that a lot of key lifts career, specifically his time at Google and this current stint as FDA commissioner, he's been spending it quote, tireless tirelessly dedicated to the task of

removing the obstacles facing the four IR. So I think, you know, since the four IR is a really key part of understanding who Califf is why he was nominated by the Biden administration to be in this particular role, at this point of time, it's all very important to understanding those issues. Right. So if it's cool with you, let's go over, you know, for people who may not know what the fourth industrial revolution is,

what are qlf stated views about the phenomenon? And what are some of his roles in at the FDA and Google that he's played in promoting these policies?

MB

Sure. One of his greatest achievements, according to him, is convincing them President Obama, that the Fourth Industrial Revolution was real and happening and very important. So he's very, he's very much a fan. And he thinks that it is important, he thinks that that will be happening. And basically what the whole concept is, is that our bodies and then eventually, our minds will eventually merge with

technology, and the internet by proxy. So this is the concept is the brainchild of Klaus Schwab runs the World Economic Forum. So, you know, the whole idea of the Fourth Industrial Revolution is to gather as much data passively generated by either people or the environment, via wearable devices, electronic health records, insurance claims, you know, the devices in your car, your social media to get it to make you your digital self. They'd like to merge your physical self with your digital

self into one thing, so totally inseparable. But he, you know, he cites Klaus Schwab and the fourth industrial revolution book that he wrote in his papers, academic papers. He talks about it frequently in interviews and things like that. Yes, that's really his contribution as he I mean, he's been, he's stated that he's gone to the World World Economic Forum, and I'm sure he, you know, Knievel's on the other acolytes there.

WW

He's openly said that lead he, you know, attended the WEF, and was like, Wow, these guys are really on to something in a video, I saw him where he's doing some Google interview series. I mean, he talks very glowingly about all of this stuff. And in the web itself. And of course, as you note in the piece, some of the stuff he's overseen, as you know, follows the web's favorite model, the public private partnership, so he seems very much on board with a lot of this

stuff. And what's particularly concerning to me is that a lot of these for IR technology, so like, you know, the way it's described, it's something that's not just going to revolutionize healthcare, right? It's supposed to revolutionize every sector of society, society itself changed the meaning of what it is to be human, and all other sorts of stuff. But the way they seem to be going to get sort of this, their foot in the door here is

is through healthcare. And you know, as I wrote for tea lab a few years ago, that particular policy has its ties with Google going way back to the, you know, well, before COVID, with the Eric Schmidt led national security commission on artificial intelligence, of course, Eric Schmidt, being the longtime head of Google. And that particular Commission said that the best way to get AI mass adopted by the American populace was to have it sort of shoehorned into health care

policy. And they essentially have framed this as a national security imperative. And so on this commission, you know, you have big tech, and you have the national security state, you know, mainly the military and intelligence communities and this is their, their view, you know, the most powerful actors really in the United States today that it's a national security imperative to have basically the the four IR types

of technologies implemented into our healthcare system. First as a way of having them spread throughout society, and they frame this as, as you know, necessary to counter China's AI supremacy and hegemony that will, you know, allegedly happen if we don't surpass China in terms of the mass adoption of

these types of technologies. But oddly enough, you know, if you really want to believe it take national security agencies at their word, you know, that this was about China, not about like long standing agendas of theirs to mass surveillance, you know, of mass surveillance and things like that, you know, obviously, that's, that's up to you, and everyone can have their own

opinion about that. But it seems like Robert K lifts roll here and more, you know, even bigger than Califf, really is the role of Google and all of this, it's definitely something I think more people should be paying attention to, at the very least. So one interesting thing that you bring up in this article is about Robert Califf, and you already mentioned it a little bit that He was the founding director of the Duke Clinical Research Institute, which predates his time working at the

FDA, but it sort of saw him partner up with the FDA. While he was at Duke, where I believe he's been for a decent amount of his academic career. And this is sort of a precursor to a lot of the stuff that he's overseen since he got involved with the FDA and overtly with Google as well. So can you tell us a little more, you know, maybe a little more detail about this Clinical Research Institute, he helped create and the initiative that you mentioned early, earlier, the clinical trials

Transformation Initiative? Yeah, sure. I

MB

mean, they're, they both run along the same lines. And the gold standard for clinical trials is a randomized control

trial. So they're looking for alternative fees. Because though, to do a randomized control trial, it costs a lot of money, you have to hire staff, you have to have, you have to recruit participants, you have to, you know, fly the intervention, or the placebo, and make sure that you're tracking all the information that's associated with that you have to have people enter that data and then make sure it's correct. And have like an actual trial site and how people go to

and from and compensate them for that. So it's, it takes a long time and cost a lot of money. So the aim, as far as I can tell, and from writings that he and others have written about, you know, real world evidence generation and real world data in place of randomized controlled trials, is that it cuts down on cost significantly, maybe up to 30%. And you can

definitely get it done a little bit faster. So if you already have a pool of people whose information that you already have access to, for instance, like I mentioned, the cell phone data, electronic health records, insurance claims, all that, you don't need to bother recruiting the participants, you don't need to wait for that information to come in, especially for the low risk trials that you again, you don't need informed consent for those anymore, thanks to the 21st Century Cures Act that was

passed in 2016. So you can get a lot of things done faster and more cheaply. If you use information. That's, like he says siloed siloed, and not interoperable. What do clinical research institute and the ctci are aiming to do is advocate for those those data to be on siloed so that they're free, they're shareable. And also to advocate for trials that use that kind of data instead of the randomized control trial, right, the past and that traditional sort of trials.

WW

So let's talk a little bit about what this means for you know, the average person that doesn't necessarily like you know, research these kinds of worlds very much. So like ran the way basically the way that medical and clinical trials have been conducted. Pretty much in the vast majority of the modern era, right? This initiative was about essentially replacing those trials with this real world evidence paradigm, right?

And you have a really helpful graphic about what real world data and real real world evidence is in this piece, and you know, that you wrote in some other descriptions of it that you provide in the piece. But the graphics interesting because it reminds me a lot of sort of, of the World Economic Forum's policy paper, I think from 2018, about digital ID, where

essentially all these different things are interconnected. And there's really like this centralized database for data about you and so what's what's really crazy about it to me that you know, it has, like, you know, you're in the center, right, and all these different types of data that you generate, are coming off, you know, from you and that this data is going to be used to replace a clinical trial for to prove the effectiveness of, of drugs. or wearables or, you know, brain

machine interfaces, you know, all this type of stuff. And it has stuff like, you know, disease registries, things you'd expect, right? Like electronic health records, survey data, pharmaceutical data, like what types of medicines you take, and

then the wearable stuff. But it also has stuff like consumer data, which is your buying habits, what you buy online, right, but also, social media data, you know, who what you're interacting with, what you're saying, online, what type of information you're reading, and viewing, which is interesting in the context of something I'd like to talk about a bit later, which is Robert K lifts mission to have the FDA play a major role in pre empting and debunking misinformation, which

is, which is interesting there. But the idea that all of this data, this monitoring of stuff that has never really been used in existing randomized clinical trials and stuff like social media data, and just sort of data, harvesting the stuff from people without their consent, and using that, in lieu of

randomized clinical trials, is just totally insane. And I just in this, you know, the people that wanted to put him in charge of the FDA obviously knew that he was in charge of these types of initiatives, and that he was, you know, essentially there to create the regulatory, I guess, I guess, you know, I'm calling it a regulatory loophole, but really, it's a complete alteration of the existing regulatory paradigm, to totally just replace it so that all of this fourth industrial

revolution, technology can be fast tracked and mass, you know, for mass implementation, mass adoption by the masses, but it doesn't necessarily have to use the previous paradigm to prove it any safety, any effectiveness under past metrics, right? Um, I don't know, your thoughts on that. Maybe you disagree.

MB

Um, I mean, it, the problem is, they can't really verify whether or not the information that you're receiving is good or bad. They're trying to come up with ways to do that. But I don't think that that's really feasible. So, you know, one way that Kailis has, you know, he gave a talk at Google was a Google Talks, then it's on YouTube, he mentioned, the one way, or at least one of the ways that we'll find out if these

things go wrong is if they become catastrophic. So that's, that's when we'll know how to regulate these kinds of trials is if there's like, a massive safety or efficacy, catastrophic situation that occurs, as he says, That's how things have gone in the past. But, you know, when you're talking about mega trials where, you know, over 40,000 people, and he's already done, that's, I don't know if the benefit, risk calculus

really makes sense there. So in and to be honest, I don't think that these real world evidence based trials are going to supersede randomized control trials entirely, I think that they are using them to fast track certain sort of medications and devices, at least through phase one and phase two trials. And they're doing they're applying it to

post market studies as well. So as far as actually, when the when medical devices or drugs are, have some sort of risk to them, I think they're still applying the randomized control trial. But they're, you know, they're, they're huge, they're implementing and using this as much as possible to cut down on costs and getting those things to market as quickly as

possible. And another thing too, that I've been thinking about is that I, he uses a lot of language of these being important and necessary so that those drugs and devices can be made available to the public, as you know, more quickly, and that's kind of the the pill that he gives you to swallow alongside the current near constant surveillance that he alleges will be occurring, and that is occurring. Because people need these life saving devices. Now, they don't need

them in five to seven years. But really, you're asking the consumer to adopt all the risk there?

WW

Well, we heard this with COVID, right? The same thing, like a change of the regulatory paradigm for the purpose of oh, we need to get this out faster. So we have to produce a vaccine on the timeline that's completely unprecedented. And we have to change how trials are conducted. And you know, as I've noted, in my work, and other people have noted, you know, a lot of these companies like Madonna, for example, couldn't get a product to market under the previous regulatory

paradigm. And so the emergency use authorization and a lot of these, you know, emergency measures we're used to sort of a totally change how a lot of these trials for these vaccines

were conducted. And, you know, because of the, you know, professed sense of urgency, that, you know, this idea that, you know, the risk is being taken on by the person that receives, you know, the vaccine, instead of having, you know, the FDA saying, Yeah, we can say, Well, I mean, they did say it was safe, right, but, you know, that wasn't necessarily

reflected by the trials, and it was all justified by speed. And, you know, what you're seeing here is them using speed as as the justification and also cost reduction, but you know, it's troubling stuff. And I may have misspoken earlier, what I meant is that um, so in your piece, you were talking about CTI this transformation, clinical trial Transformation Initiative, and you said it seeks to do is to use real world evidence in place

of evidence generated by RCTs. And so I sort of see what Robert Califf is doing now at the FDA sort of as not necessarily trying to replace, you know, eliminate randomized clinical

trials entirely. But when it comes to a lot of these, more like novel devices, not necessarily things like vaccines, and like pharmaceutical products that are more traditional, like pills and, and other types of injections and stuff, it seems to be some of these other devices, whether they're wearables or implantables, really also are sort of being treated under this, this new paradigm, this idea of like the remote clinical trial, it's not

necessary to physically monitor and observe patients and just basically use the data that's collected by their interaction with these devices and the connectivity. And all of that is essentially replacing traditional trials. And to me, that seems sort of like a way of sidestepping some of the traditional metrics for these particular devices, which, of course, those devices are obviously necessary to get the for IR really rolling in the healthcare space, right?

Particularly with the, you know, the brain machine interface, or some of these neuromodulation devices sort of get the nervous system of the human body connected to the internet. Right?

MB

What what's funny about that is there the breakthrough devices designation given by the FDA to medical devices is really for devices that are or to treat life threatening, or irreversible diseases, which, when you think of a brain computer interface, sure, you can maybe make the claim that our brain computer interface can treat paralysis, or help the blind see, or the, you know, stroke victims have more functioning sides of their body. Yeah, that's fine, but they also

will be applied for many, many other uses. So it just seems to me that companies like Black Rock technologies, and Syncron and neuralink, etcetera, are using this, you know, this claim that their brain computer interface will be used to treat life threatening and in or irreversible diseases as a way to get get their stuff through the door and fret and prioritize that at FDA so that it can be pushed through more quickly, you know, disregarding all the other applications that Amin B is for

and it will most likely be used for and that's probably what they're, what their primary aim is at the end of the day.

WW

So even though you mentioned that, like the breakthrough device designation, technically is sort of, like reserved for these devices that are like for, you know, irreversible, you know, diseases, terminal illnesses and conditions, stuff like that. It's being given to a lot of things that don't follow

under these metrics. So a recent FDA breakthrough device designation was given to this company called Suma, which is very much you know, it's basically Soma but with a second Oh, and it received that designation for its innovative at home depression treatment device, which it describes basically well in the picture in the article anyway, it's basically like a electrodes you were on like a weird little

beanie thing over your head. And like a electroshock see you I guess, certain parts of the brain to like, make you not depressed, right. But there's a lot of other treatments for depression, right? And breakthrough device designation as opposed to be for conditions that don't have existing treatments, you know? So, this is one of those examples of sort of the FDA sort of applying this designation to places where it

doesn't really need to be given right. And so you know, if you look at this example, and a few others, it seems pretty clear that the current FDA modus operandi as it comes to this brand, As it relates to this particular designation, it seems to just sort of be giving it to companies that, you know, have some of these four IR related devices or, you know, neuromodulation stuff specifically, and trying to get them onto the market as quickly as possible, allegedly for the

benefit of consumers. But, you know, when you get these sort of special designations, you're allowed to sort of skip a lot of the, you know, the regulations and trials and other requirements that, you know, competitors would have to complete, you know, competitors that don't receive this particular designation.

MB

Yeah, right. I mean, what's the breakthrough device designation also allows for novel medical devices, they call it de novo. So there's no you know, to be a de novo device, there's not any legally marketed predicate device, so something like it. As far as I know, Suma has at least some competitors. I saw other sort of beanie electrode app applications and devices a lot like it. So maybe they're competing for that

space. My My initial thought when I saw the, their device had the head cap and the electrodes, I thought we had already kind of tried electro thought shock therapy for mental illness, and that it didn't really work too well, and also made people a little bit weird. And not it was not good. So I think I mean, I understand that it's a little bit more low voltage. But it

doesn't seem to be too original of an idea. But, yeah, as far as I see, yes, they use a technique called transcranial direct current stimulation we really neuromodulation is well, there are a few different definitions that I was able to find. But they're mostly that the international neuromodulation society defines it as the alteration of nerve activity through the targeted direct delivery of a stimulus through electric or chemical agents at certain sites, so we have a lot

of companies that are looking at the spleen. Let's just saying what does that nerve called, there's a there's a certain nerve that that originates at the spleen. And it's part of the autonomic nervous system. And they're looking at that for Parkinson's to stop the hand tremors. Yeah, so you have a lot of people looking at that for that. And they also are trying to use it for rheumatoid arthritis, and things like

WW

that. So one of the companies pursuing neuro modular neuromodulation of that particular nerve, you mentioned, I guess, the spleen at nerve is for rheumatoid arthritis is Galvani bioelectronics, which is an interesting company in the context of Robert Califf, because it's a joint venture of GlaxoSmithKline. And verily, which is Google's health subsidiary that Robert Califf has been involved with over the

years. And they're one of the ones that sort of got this. I think they've already started implanting it into people, but they have a lot of ambitions for these neuromodulation advices, which is basically to alter how the nervous system functions, whether it's targeting specific nerves, or many nerves, or groups of nerves, or the entire brain. That's sort of the whole ambition there. And of course, verily, is also the people behind project baseline, which is something that you mentioned

earlier. And I think not enough people have paid attention to this. And it's a really crazy thing when you think about it. So, um, there's this one, there's a few things that have been written on baseline, you know, from mainstream sources. So one summary offered here and which you sort of have touched on already and what you've talked about, it says, The verily baseline Health Study launched in 2017. So that's around the same time that Califf was at Google on being their top

health strategist, right. It was launched in 2017, with the goal of mapping human health by collecting data from a variety of sources, including self reported data, smartphone, or wearable recorded data, or through electronic health records. And as you mentioned earlier, because of the the Cures Act, some of that recorded data by smartphone or wearables that data can be obtained without informed consent.

Anyway, so it says essentially, a lot of this, this baseline health study, and the broader baseline health platform is all about changing. Again, how clinical trials function, right? So I first heard about Project baseline during the COVID stuff

because they were using it specifically for that. And a bunch of weird stuff was going on with verily and COVID tests, including having people forcing people who took COVID-19 test and the San Francisco area which were being managed I think the government there, or had contracted Google or verily, to do this, and they were requiring people that got COVID test to basically link their test results to their Google account. And if they didn't have a Google account, they had to make one in

order to participate, which is pretty insane. But essentially, what it sounds like to me is that project baseline is just trying to gather an insane amount of, of data on people for all different types of purposes. And essentially, the goal they say, is to collect comprehensive health information with the goal of better understanding health and the transition to disease.

And it's important to keep in mind that at the same time this has been going on and when this was launched, is when the Pentagon and Google teamed up for this sort of predictive health care thing. So basically, using all of this data, all of these, this massive cachet that military holds from, like the veteran and military health systems of X ray images, and things like that, to train AI so that the AI could offer

predictive cancer diagnoses. So basically, the AI is like, Oh, well, we've decided that you'll develop cancer in five years, but you don't actually have cancer, you know. So it's all of this sort of, you know, what I've, what me and people like Ryan Christian are sort of referred to as the pre crime

paradigm applied to healthcare. So basically, you're going to be told that you're going to develop this disease by AI, or some of these different devices or by you know, this data accumulation, and they're going to decide, they're going to tell you what you're likely to develop before you develop it, and then go and offer you all these different weird therapeutics, whether it's stuff like, you know, mRNA stuff, or gene therapy, or, you know, these neuromodulation devices,

or wearables are stuff that interacts, you know, with your nervous system, or changes how it functions and all sorts of stuff, even though at that particular moment, you don't actually need it, it's being framed as preventative. Right. And this is, again, Google with the military doing this, and you have them of course, doing it, and all other sorts of, of different guises. But ultimately, you know, it's about

per them about health care. Right? But it seems to be a lot more than that, if you asked me, but, you know,

MB

yeah. And Kayla's. In an interview, he mentions that this sort of, you know, influence subtle influence over people in regards to their health is, you know, justifiable because it's already happening. And it's been happening for a while through, you know, private market advertisements, and cookies on your computer and tracking what you buy, and figuring out what you might be interested in buying, and then presenting that to you. So he's just in he thinks that doing that isn't

necessarily good. It's not getting people, things that they need, or make them have a happy or healthier life. So what he's saying is, well, that's bad when we do it, it's good, because we're trying to help people live longer and be less ill. So we're going to track you and just the same way, we're going to nudge

you and influence you in just the same way. But our ends are delivering those drugs and those medical devices that you actually you need, right, and you'll be convinced that you need them because we have all the data, and we'll present you evidence that we found and tell you how this will help you and your life before you are even considering going to the doctor about it. But like you said it is it is preemptive. And he thinks that it's totally fine. There's there's good guys and

bad guys. And the bad guys are the people who sell you clothes and food and stuff like that. But they're good because they sell you pharmaceutical, drugs and medical devices.

WW

Yeah, crazy. So. So in your particular article in talking about the Cures Act, you sort of mentioned that Califf had a role and getting that certain aspects of that legislation, you know, in place, you know, involved in to an extent in the drafting and

lobbying process for this particular law. And so I found it interesting, too, that rolled within that act, were things like the BRAIN Initiative, and Biden's Cancer Moonshot Initiative, which, you know, is was basically the basis for Biden's recent creation of ARPA H, which was previously shopped around to the Trump administration under the name of

Harper. And we're basically a health focused DARPA equivalent and I actually did a podcast a few months ago about one of the guys behind the BRAIN Initiative and how he has been very active where I live down in South America in Chile and getting Chile to be the first country to establish what he what are called neuro writes. This idea of trying to protect your individuality and so Out of this paradigm where brain machine

interfaces, and all of this are, are very common. And essentially, you know what I sort of talked about this likely being in that particular podcast, instead of it being framed as protecting you from all the bad stuff these devices could do to you. Making you lose your sense of self, among other things, is really about creating the necessary framework and public justifications to get these types of devices on the market, not necessarily for healthcare related purposes, but

also for commercial purposes. Because people like Elon Musk, like neuro link and stuff, you know, on one hand, they're saying and I guess Syncron, to probably in some of these other firms doing the same thing, you know, on one hand, they're framing this as Oh, this is a health device to help people that are paralyzed, walk, and, and all and blind people seeing all of that, but at the same time, you know, Elon Musk is like, pretty open, that neuro link is intended to be like,

used for commercial purposes, people could use it to play video games and stuff. And you know, even some of the animal trials, they promoted were like monkeys with the neuro link implant playing video games with their brain and stuff, not paralyzed monkeys walking again, you know what I mean? So it just seems, you know, a bit different than it's being done, it's being sold.

MB

Sure. I think, you know, for the brain computer interfaces, the only, there's a difference between imagination and reality. And you can, you know, postulate and say that our BCI is going to help people walk or see or whatever, I don't see any evidence of that, at least as far as like the initial studies and video footage and things like that, that there's no

evidence for that actually happening. As far as what is able to be accomplished is that you can control like, so if you're a total, if you're 100%, paraplegic, and you have no way to move your hands or interface with a computer, you can do so they say, quote, unquote, simply by thinking, and while that may have medical application, you know, if you're trying to help people who are paralyzed, sure, but Why can't anybody else use

it for that? So it's just to pass it under the guise and get these sort of fast tracks to market seemingly to preempt your competition and kind of monopolize that market as soon as you can. Which is, I would say, Syncron is definitely much further ahead than than anybody else on that front. That seems to be what it's actually for. Because I don't I don't, you

know, the brain computer interfaces. There's, there's just not enough evidence out there to suggest that it's actually going to help people with with their claims of you know, the ever irreversibly debilitating diseases or the life threatening diseases. There is one company it's called, see things called like neuro neuro links or neuro leaf, that's what it is. They have this brain computer interface that links with an exoskeleton that helps people who have you know, have

had a stroke, move the hand, that's not working anymore. That makes more sense. But yeah, it seems more just trying to get these things on the market as quickly as possible under the guise of helping people as

WW

Yeah. And what I mentioned earlier, there's this whole, you know, ulterior motive coming from the highest levels of the national security state and people like Eric Schmidt, trying to get the stuff out there on the market as quickly as possible because they see it as part of this big tech war with China. Right. Which is also pretty crazy. And, you know, a

key point I want to make here too. So I'm sure people are familiar with, you know, my analysis and other people's analysis of statements made by by people tied up with the World Economic Forum and big you know, for IR evangelists, like Yuval, Noah Harare, who basically say that, like the whole wearable paradigm, like getting wearables on everybody is the red line that will, you know, result in the ushering in of what he calls digital dictatorships, you know, basically the surveillance of

what's going on not just inside your body, but inside your mind. And I think this is all kind of interesting when you're looking at the big players here in the context of a lot of how this mass surveillance is also, you know, tied into this, this effort to launch a war on domestic terror and master bail everybody and sort of usher in the paradigm they tried to do after 911 with things like DARPA is total information awareness

and stuff. So you know, you have groups like Google and also Palantir, which is basically you know, as I've noted in my work, essentially a CIA front that is basically total information awareness, privatized and so Palantir basically has access and has been running a lot of the COVID-19 health data and other health data held by HHS and also in the United Kingdom. Basically, all NHS data is being managed by Palantir is Well, and

then you have Google having this this big role. For example, they host the FDA is my studies program, and how on Google Cloud and they have for some time, and you have a lot of these, you know, this revolving door, like we talked about earlier, sort of between the, the regulatory agencies and Google and verily is being used for a lot of these new remote trials to get some of these, you know, more novel devices, I guess, and like neuromodulation devices on the market more quickly, without,

you know, in person monitoring and, you know, completely electronically conducted fully remote clinical trials in they're teamed up with the Pentagon. I mean, there's all

sorts of crazy stuff going on here. And I think some of that overlap is interesting in the context of this whole, like, you know, misinformation trying to stop people from spreading what's deemed as misinformation about about health and how that also is, you know, one of the main objectives of the supposin war on domestic terror, because Robert Califf has been very vocal, since he came in to art it's came into this position last year about the need for the FDA as an agency to preempt and

debunk misinformation, which is kind of ironic, because some of their efforts on that front have actually involve the FDA spreading the misinformation, for example, claiming that ivermectin is not like, able to be used in human beings that it's like a horse and cow medicine exclusively. And regardless of what you think about its validity as an early treatment of COVID, or whatever, well, before the COVID era, it

was being used in people. So to frame it, as you know, a horse to warmer exclusively, like had been done on CNN is not accurate. And the FDA obviously knows this. So it's just interesting that you'd have you know, Google Palantir, they're big players in the healthcare secure system getting more and more tied up with the FDA. And they're a big part of this misinformation, crackdown and profiling of people spreading

misinformation as well. And I think people, you know, might be might want to see that there's that degree of overlap there. Because once you're surveilling people, whether it's under the guise of healthcare, or under the guise of stopping domestic terrorism, I mean, ultimately, I think the end result is the same

essentially. And I've also kind of argued, and in some of my work on, on the creation of ARPA H, under the Biden administration, which sort of goes back to this Cures Act stuff you were talking about during the Obama administration, I mean, essentially, that's also about getting the mass use of wearables for this, you know, predictive health paradigm and precision health paradigm and all of this stuff. So, you know, it may be it's being framed as you know, a boon for public

health. But ultimately, it seems to me like the four IR is just about an insane paradigm of mass surveillance, and they're just trying to see what sort of justifications they can make for it, you know, what sticks and what people, you know, need to believe and need to feel in order to start using that type of technology on and in their bodies.

MB

Yeah, I think that's the fourth industrial revolution, you know, well, Klaus Schwab. And, you know, the people who are as true believers, they describe it as the merging of our personal and digital selves, right, or quantify cells. But it's really about the last frontier, which is the mind,

right, and also, including genetics. So they're looking to somehow be able to predict, and they've been, you know, the US government, at least for a long time has been created, create a artificial artificial models of the world and tried to use that to predict how military conflicts would go, or certain the certain release of information would go, they created a computer generated models of the world and people to the finest detail possible, hoping that they can predict the

future. And really, they need a comprehensive understanding of how people think. And I think that's really what it's about the mind is really the last frontier, and genetics for capitalism and in any in governments and surveillance and control. So that seems to be to be the primary target by merging people's physical and digital selves. And while you know, they frame it as that's something that will happen eventually. And inevitably, the private market and the public private market

are kind of already doing that intentionally. So they're, you know, whether or not that would have happened otherwise, is another question, but they're kind of making that happen now. And as far as, as far as the surveillance stuff goes, this is why I think artificial intelligence is so important is, you know, considered to be an arms race at the moment between

the US you know, and They're competitors. Because it's a lot of information, that's a lot of data, it's impossible to go through all of that and assign patterns with any sort of efficiency. So you need to apply an algorithm machine learning algorithm or an artificial intelligence to that, to find what you're looking for, or to at least flag what it thinks it

might, you might be looking for. And as far as, you know, the Patriot Act, and the NSA goes there, their current release their policies were to have a black box where all this you know, depersonalized information lives until there's reason to go and look through it. Because a person can't go and just look through the information to find what they think is a probable cause to fill it further. But you can't legally have an

artificial intelligence do that, because it's not a person. So essentially, what is what at least to me, what seems to be the probable outcome is that there will be many more false positives, many more flags, and many more issuances of probable cause to look into people even further. And, you know, to pull up to the fullest extent, then there was before because there's going to be many more patterns, or have a sense, you know, patterns. What is that? Who's Who's writing those artificial

intelligence, intelligence programs? And what did they consider to be a pattern of, you know, domestic terrorism or anything that would warrant probable cause. So that I mean, and something that I read recently from you is about Gabriel and the artificial intelligence surveillance software that's being applied through things like cameras and, and sound. So it's certainly in the realm of technology, something that is possible, especially if it's all in a readable format, in text or ENCODE.

WW

Well, thanks for that really great summary about a lot of really complex issues and how it all ties together. And you know, a lot of what you know, we're facing, I think people need to pay a lot more attention to the healthcare space, particularly people who were opposed to stuff like the Fourth Industrial Revolution, and its encroachment on our lives and our government and really society in general, because, you know, they're

trying to get a huge foot in the door through health care. And I would argue, and I actually have argued, I think, in some interviews I've done over the past year that Robert Califf is at the FDA right now explicitly for this purpose, like, as you note in your piece, he's there to remove a lot of these obstacles from this for IR paradigm for being ushered in, you know, sort of in through the healthcare system first, you know, he's the point man for that. So I think he definitely deserves a lot

more scrutiny. And that's why I was so happy to find your piece about him. And very happy to have you on today to talk about him. And these, you know, more broad these broader issues on my podcast. So thanks so much for coming on Maddie. So where can people follow your work, and support you.

MB

So you can follow it on the last American Vagabond substack, which is Te L A vagabond.substack.com. That's where most stuff is. I also post on manufacturing reality.org, which is James journeys blog there, where he also contributes, and stuff like that. So those are really the main two sources, you can support me by supporting tila. And, and you can follow me on Twitter, and that space jelly. If you just search she'll find me eventually.

WW

All right, super. Well, thanks so much, Maddie, for coming on. Really appreciate your time looking into these issues. And I'm looking forward to following more of your work here in the future. And thanks to everyone for listening to this podcast, and hopefully some people listening will take the time to look into some of these deeper issues as well, because they really, you know, as I mentioned in the introduction, there is a extreme lack of reporting, not just on Robert K

lift, but a lot of the issues we touched on today. And I think we ignore this kind of stuff at our own peril. So definitely, there's a lot to dig into. And you know, we really just scratched the surface about a lot of these issues today. And of course, as always, a big shout out to unlimited hangout supporters who make this podcast and pretty much all of my other work possible as well couldn't do it without you guys. So thanks so much. And thanks, of course, to everyone who

regularly listens and shares this podcast around. Appreciate you all as well. So thanks so much everyone for listening and catch you on the next episode.

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